The Mostdi ™ dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.

Device Description

Mostdi™ dental implant system consists of one piece screw type endosseous dental implants manufactured from titanium alloy and intended to provide support for prosthetic devices such as bridges and removable dentures in order to restore a patient's chewing function.

AI/ML Overview

The Mostdi Dental Implant System (K132178) is a dental implant system consisting of one-piece screw-type endosseous dental implants made from titanium alloy. It is intended to support prosthetic devices like bridges and removable dentures for treating partial or full edentulism. The device can be immediately loaded if good primary stability and appropriate occlusal loading are achieved.

The manufacturer did not conduct a clinical study to prove the device meets acceptance criteria. Instead, substantial equivalence was claimed based on a comparison to predicate devices, supported by non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

The submission explicitly states that the substantial equivalence claim relies on having "the same device characteristics as the predicate devices," with similar "intended use, material, design and use concept." No specific numerical acceptance criteria or performance metrics derived from a study are provided beyond the general assessment of similarity to predicate devices. The "reported device performance" is essentially that it passes various non-clinical tests and is deemed substantially equivalent to existing, legally marketed devices.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance
Material Composition	Made from Ti6Al4V ASTM F-136 (same as predicates)	Ti6Al4V ASTM F-136 (matches predicate material)
Design Type	One-piece screw-type endosseous dental implant (same as predicates)	One-piece screw-type (matches predicate design type)
Implant Surface	Roughened (light sand blast & acid etch), comparable to blasted/clean surfaces of predicates	Roughened - light sand blast & acid etch (considered comparable to predicate surfaces)
Dimensions	Diameters and lengths within ranges comparable to predicate devices	OSH: 2.5, 3.0 dia. & 8,10,12,13,14,16 length; MXO: 3.5 dia. & 8, 10 length; PEO: 3.8 dia. & 10, 12, 14, 16, 18 length; POH: 2.5, 3.0 dia. & 8, 10, 12, 13, 14, 16 length; MXP: 3.5 dia. & 8, 10 length; PEP: 3.8 dia. & 10, 12, 14, 16, 18 length (comparable to predicates)
Intended Use	Support for removable dentures and fixed bridges for partial/full edentulism; immediate loading possible with good stability and appropriate occlusal loading (comparable to predicates)	Matches intended use of predicate devices, including immediate loading conditions.
Biocompatibility	Biocompatible for dental implant use (implied by material and predicate equivalence)	Biocompatibility testing performed (details not provided in summary, but indicated as reviewed)
Sterilization	Sterilization validation (implied by predicate equivalence)	Sterilization validation performed (indicated as reviewed)
Shelf Life	Stable over a specified shelf life (implied by predicate equivalence)	Shelf life testing performed (indicated as reviewed)
Fatigue Performance	Meets fatigue requirements (e.g., ISO 14801/static test) for dental implants	Fatigue tests to ISO 14801/static test performed (indicated as reviewed)

2. Sample Size Used for the Test Set and Data Provenance:

No clinical test set was used for a study comparing the device against acceptance criteria in the context of this 510(k) submission. The submission relies on non-clinical benchmark testing (e.g., fatigue, sterilization, shelf life, biocompatibility, surface analysis) and a a comparative review against predicate devices. Therefore, there is no sample size for a "test set" in the traditional sense of a clinical study, nor specific data provenance (country of origin, retrospective/prospective) for such a set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. As no clinical test set was used to establish an efficacy or performance ground truth, there were no experts establishing ground truth for such a test set. The substantial equivalence determination was made by the FDA based on the provided technical documentation and comparison to predicate devices, and internal FDA reviewers are the "experts" in this context.

4. Adjudication Method for the Test Set:

Not applicable. Without a clinical test set, there is no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a dental implant device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device (dental implant), not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" used in this submission is the established safety and effectiveness profile of the identified predicate devices. The manufacturer's claim of substantial equivalence is based on demonstrating that the Mostdi Dental Implant System is as safe and effective as, and performs as well as, the legally marketed predicate devices. The non-clinical tests (fatigue, sterilization, shelf life, surface analysis, biocompatibility) serve to confirm the physical and biological characteristics align with the expected performance of an endosseous dental implant made from the specified material, which is consistent with the predicates.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. There is no concept of a "training set" as would be found in algorithm development for AI/ML.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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K132178

APR 3 0 2014

510(K) SUMMARY

Submitter:

Ang Moe Keng Mostdi Innovations Sdn Bhd No 5, Jalan Damai Puspa 1, Alam Damai, 56000 Kuala Lumpur Malaysia Phone: +603-9101-1089 +603-9101-0834 Fax:

Consultant /US agent:

Susan Park Kodent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 USA Phone: 714-525-0114 Fax: 714-525-0116

Device Information

Device Name: Mostdi Dental Implant System Classification Name: Endosseous dental implant Common Name: Dental implant Panel: Dental Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date prepared: 7/10/2013

General Description

Indications for Use

Testing

The following were reviewed to support the performance of Mostdi™ dental implants: Fatigue tests to ISO 14801/ static test, sterilization validation, shelf life testing, surface analysis & biocompatibility testing.

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Substantial Equivalence

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Areas of Comparison	Mostdi Dental Insplant System	Intra-Lock® OP Dental Implants	Mini Drive-Lock™ Dental Implant System	Lew Mini O-Ball implant	IMTEC Sendax MDI and MDI Plus
Regulatory Status	Present Application	Predicate	Predicate	Predicate	Predicate
510(k) Number	K132178	K130140	K070601	K121707	K031106
Material	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136	Ti6Al4V ASTM F-136
One Piece/ Two Piece	One piece	One piece	One piece	One piece	One piece
Type Implant Surface	Roughened-light sand blast & acid etch	Blasted	N/A	Blasted and clean (SLA equivalent), machined surface, SE to IMTEC K031106	N/A
Dimensions (mm)	OSH: 2.5, 3.0 diameter and 8,10,12,13,14,16 threaded lengthMXO: 3.5 diameter and 8, 10 threaded lengthPEO: 3.8 diameter In 10, 12, 14, 16, 18 threaded lengthPOH: 2.5, 3.0 diameter in 8, 10, 12, 13, 14, 16 threaded lengthMXP: 3.5 diameter for 8, 10 threaded lengthPEP: 3.8 diameter for 10, 12, 14, 16, 18 threaded length	3.0, 3.75, 4.0, 4.75 diameter, 10 - 15 threaded length	2.0. 2.5 diameter, 10, 11.5, 13, 15, 18 threaded length	2.0, 2.5, 3.0 diameter, 10, 13, 15, 17, 18 threaded length	N/A
Product Code	DZE	DZE	DZE	DZE	DZE
Indications for Use	The Mostdi " dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.	The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also Indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate ocdusal loading in order to restore normal teeth function, 3.75mm, 4.0nm and 4.75mm Intra-LockS OP Dental Implants: Intra-Lock") implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to	Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Dive-Lock TM Dental Implants are indicated for long-term maxaltary and mandibular tissue- supported denture stabilization, Multiple implants should be used and may be restored after a period of time or placed in immediate function.	The Park Dental Research Corporation's LEW O-ball implant system is a self- tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini 0-ball implant may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm, 2.5 mm, and 3.0 mem diameter are intended to support single or multi-unit restorations in both long- term and temporary applications	The MDI and MDI PLUS are self-tapping titanium threaded screws Indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter. radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention,

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . .

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		replacement to full archreconstruction. Intra-Lock®Implants are intendedfor immediate function on singletooth and/or multiple toothapplications when good primarystability is achieved, withappropriate occlusal loading, inorder to restore normal teethfunctions.
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Summary of Substantial Equivalence Comparison

The Mostdi Dental Implant System has the same device characteristics as the predicate devices. Intended use, material, design and use concept are similar.

Slight differences in design characteristics do not affect the application of the device. Therefore, we state that Mostdi™ dental implants is substantially equivalent to predicate devices.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Mostdi Innovations Sdn Bhd concludes that Mostdi Dental implant System is substantially equivalent to predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 30, 2014

Mostdi Innovations Sdn Bhd C/O Ms. Susan Park Kodent, Incorporated 325 North Puente Street, Unit B Brea, CA 92821

Re: K132178

Trade/Device Name: Mostdi Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 1, 2014 Received: April 1, 2014

Dear Ms. Park:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Park

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known) K132178

Device Name: Mostdi Dental Implant System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green =S 2014.05.01 11:37:44 00'

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.